Von Hexenverfolgung und Hypothesenverlust

Zusammenfassung

„Eine gefaßte Hypothese gibt uns Luchsaugen für alles sie Bestätigende und macht uns blind für alles ihr Widersprechende“, sagte einst Arthur Schopenhauer. Über hundert Jahre später hat seine Aussage immer noch Bestand: Die klassischen erkenntnistheoretischen Methoden gehen in der Medizin zunehmend verloren und die Voraussetzungen großer randomisierter Studien werden kaum hinterfragt. Das kann gefährlich werden.

Abstract

At this time randomized controlled studies (RCT) in clinical trials usually have high quality. But this quality is only true for the included patients (intrinsic validity). It is common to generalize the results to more or less similar patients. This inductive method is prohibited in epistemology what is known for 250 years (D Hume, K R Popper). Therefore the external validity for the data of RCT is low. To solve this problem additional clinical and pathophysiological based data are necessary to generalize the results. Unfortunately RCT show less quality in their premises. This is partly due to the influence of the pharmaceutical industry. A loss of universality of the hypothesis for RCT decreases basically the extrinsic validity. The articles describe this problem with examples.

Schlüsselwörter

Erkenntnistheorie - evidenzbasierte Medizin - Validität

Keywords

epistemology - evidence-based medicine - validity

• Literatur

• 1 Kramer H. Der Hexenhammer: Malleus Maleficarum. Jerouschek G, Behringer W, Hrsg München: DTV; 2000
• 2 Popper KR. Logik der Forschung. Zur Erkenntnistheorie der modernen Naturwissenschaft. Wien: Julius Springer; 1935
• 3 Steg PG, López-Sendón J, Lopez de Sa E et al. GRACE Investigators. External validity of clinical trials in acute myocardial infarction. Arch Intern Med 2007; 167: 68-73
• 4 Travers J, Marsh S, Caldwell B et al. External validity of randomized controlled trials in COPD. Respir Med 2007; 101: 1313-1320
• 5 Bateman ED, Hurd SS, Barnes PJ et al. Global strategy for asthma management and prevention: GINA executive summary. Eur Respir J 2008; 31: 143-178
• 6 Travers J, Marsh S, Williams M et al. External validity of randomised controlled trials in asthma: to whom do the results of the trials apply?. Thorax 2007; 62: 219-223
• 7 Lundh A, Sismondo S, Lexchin J et al. Industry sponsorship and research outcome. Cochrane Database Syst Rev 2012; 12 MR000033
• 8 Lundh A, Barbateskovic M, Hróbjartsson A, Gøtzsche PC. Conflicts of interest at medical journals: the influence of industry-supported randomised trials on journal impact factors and revenue – cohort study. PLoS Med 2010; e1000354
• 9 Rosenberg W, Donald A. Evidence based medicine: an approach to clinical problem-solving. BMJ 1995; 310: 1122-1126
• 10 Pitt B, Zannad F, Remme WJ et al. The effect of spironolactone on morbidity and mortality in patients with severe heart failure. Randomized Aldactone Evaluation Study Investigators. N Engl J Med 1999; 341: 709-717
• 11 Juurlink DN, Mamdani MM, Lee DS, Kopp A et al. Rates of hyperkalemia after publication of the Randomized Aldactone Evaluation Study. N Engl J Med 2004; 351: 543-551
• 12 Rivers E, Nguyen B, Havstad S et al. Early Goal-Directed Therapy Collaborative Group. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med 2001; 345: 1368-1377
• 13 Perner A, Haase N, Guttormsen AB et al. 6S Trial Group; Scandinavian Critical Care Trials Group. Hydroxyethyl starch 130/0. 42 versus Ringer‘s acetate in severe sepsis. N Engl J Med 2012; 367: 124-134
• 14 ProCESS Investigators. Yealy DM, Kellum JA, Huang DT et al. A randomized trial of protocol-based care for early septic shock. N Engl J Med 2014; 370: 1683-1693
• 15 Mouncey PR, Osborn TM, Power GS et al. ProMISe Trial Investigators. Trial of early, goal-directed resuscitation for septic shock. N Engl J Med 2015; 372: 1301-1311
• 16 Köhler D. Benutzen wir die falsche Zielgröße in der supportiven Sepsistherapie?. Dtsch Med Wochenschr 2015; 140: 439-442
• 17 Rossaint R, Falke KJ, López F et al. Inhaled nitric oxide for the adult respiratory distress syndrome. N Engl J Med 1993; 328: 399-405
• 18 Guerin C, Gaillard S, Lemasson S et al. Effects of systematic prone positioning in hypoxemic acute respiratory failure: a randomized controlled trial. JAMA 2004; 292: 2379-2387
• 19 Noah MA, Peek GJ, Finney SJ et al. Referral to an extracorporeal membrane oxygenation center and mortality among patients with severe 2009 influenza A(H1N1). JAMA 2011; 306: 1659-1668
• 20 Gao Smith F, Perkins GD, Gates S et al. BALTI-2 study investigators. Effect of intravenous β-2 agonist treatment on clinical outcomes in acute respiratory distress syndrome (BALTI-2): a multicentre, randomised controlled trial. Lancet 2012; 379: 229-235
• 21 Tanaka LM, Azevedo LC, Park M. ERICC study investigators et al. Early sedation and clinical outcomes of mechanically ventilated patients: a prospective multicenter cohort study. Crit Care 2014; 18: R156
• 22 ARDS Definition Task Force. Ranieri VM, Rubenfeld GD, Thompson BT et al. Acute respiratory distress syndrome: the Berlin Definition. JAMA 2012; 307: 2526-2533
• 23 Zenri H, Rodriquez-Capote K, McCaig L et al. Hyperoxia exposure impairs surfactant function and metabolism. Crit Care Med 2004; 32: 1155-1160
• 24 Altemeier WA, Sinclair SE. Hyperoxia in the intensive care unit: why more is not always better. Curr Opin Crit Care 2007; 13: 73-78
• 25 Rothen HU, Sporre B, Engberg G et al. Prevention of atelectasis during general anaesthesia. Lancet 1995; 345: 1387-1391